Chronic Pain
Conditions
Keywords
chronic pain, virtual reality, Occupational therapy, debriefing, self-efficacy, fear of movement
Brief summary
This study will determine if occupational therapy or the combination of occupational therapy and virtual reality is the better treatment for chronic low back pain (CLBP)patients.
Detailed description
Chronic musculoskeletal pain is defined as persistent or recurrent pain lasting more than 3 months. Chronic pain is a complex and disabling physiological and psychosocial disorder that does not provide an adaptive or protective purpose. In chronic pain, the precipitating event (e.g., fracture, sprain, trauma) is healed, and yet excessive pain remains. In Immersive Virtual Reality (IVR) people experience a three-dimensional, computer-generated environment via a computer headset. IVR has been used to treat acute pain, but there have been few focused studies on the effects of IVR on chronic pain. When people with chronic pain are in IVR, they become unaware of their body and tend to move normally. We would like to test to see if IVR has a lasting effect in this study. Thus, IVR has strong potential as an additional tool in an arsenal of treatments for chronic pain. This study will examine if IVR can reduce pain and other symptoms in people with chronic pain.
Interventions
OTHEROccupational Therapy
Occupational therapy helps individuals with chronic pain to participate in daily activities in an adaptive way. The subjects will be provided with customized plans and objectives to address their self-care, vocational, and leisure goals. This includes education, home exercises, stress management, home safety, energy conservation, and work simplification - all of which promote a safe return to daily activities.
OTHEROccupational Therapy +Virtual Reality
The occupational therapy +VR utilizes the regular therapy sessions along with providing a Virtual reality headset to relieve pain. After each VR session, there will be a debriefing from the therapist.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages 18 and older * Referred for chronic pain occupational therapy services at the UPMC Centers for Rehab Services Centre Commons site.
Exclusion criteria
* Had a seizure, loss of awareness, or other symptom linked to an epileptic condition * Had virtual reality intervention within the last 3 months * Has sensory insensitivity such as hearing loss or low vision, as assessed by the PI * Has contagious disorder on the face, such as pink eye, that could be transmitted via the VR headset or has open areas on the face that would come in contact with the headset * Has a pacemaker or defibrillator * Insufficient upper extremity coordination to operate IVR controls, as assessed by the PI * Insufficient cognitive ability to answer questionnaires or learn to use the IVR, as assessed by the PI * Have a diagnosis of ASD (Autism Spectrum Disorder) or unable to understand and/or respond in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from Baseline in average rating of chronic pain at 3 months using Numeric Pain Rating Scale | Baseline vs 3 months | Numeric Pain Rating questionnaire will assess how much a person hurts with a question ranked on a 11-point scale, from 0 = no pain to 10 = worst pain imaginable. The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline self-efficacy using Pain Self Efficacy Questionnaire (PSEQ). | Baseline vs 3 months | Change from Baseline Pain Self Efficacy at 3 months using Pain Self Efficacy Questionnaire (PSEQ). The questionnaire will assess how confident a person feels despite the pain with 10 questions ranked on a 7-point scale, from 0 = not at all confident to 6 = Completely confident. |
| Change from Baseline fear of movement using the Tampa Scale of Kinesiophobia (TSK). | Baseline vs 3 months | The Tampa Scale of Kinesiophobia (TSK) questionnaire will assess fear of movement with 17 questions ranked on a 1-4 scale, from 1 = Strongly disagree to the 4 = Strongly agree. Lower scores suggest lower fear of movement. |
| Change from Baseline Pain Intensity at 3 months using PROMIS-29 | Baseline vs 3 months | The PROMIS Numeric Rating Scale v2.0 questionnaire will assess how much a person hurts with a question ranked on a 11-point scale, from 0 = no pain to 10 = worst imaginable pain. The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes. |
| Change from Baseline participation and scaling at 3 months using Goal Attainment Scale (GAS) | Baseline vs 3 months | The Goal Attainment Scale will assess the response to participation based on a 5 point scale ranging from +2 = MUCH more than expected to -2 = MUCH less than expected.HIgher scores suggest higher response to participation. |
Countries
United States
Outcome results
None listed